Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Baxter International and its 65 subsidiaries with 1,878 510(k) clearances, 571 device recalls, 235 drug applications, 114 drug recalls, 3 warning letters and 3 complete response letters. The most recent is a warning letter dated Sep 29, 2026: Warning letter: Aseptic processing, Sterility assurance, Cleaning validation.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Baxter International and its 65 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
